JDSClass II
Nail, Fixation, Bone
21 CFR 888.3030 / Orthopedic
JDS is the FDA product code for Nail, Fixation, Bone, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 21 recalls.
Classification record
- Product code
- JDS
- Device name
- Nail, Fixation, Bone
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 53
- Ingested recalls
- 21
Clearances, product code JDS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 3 |
| 1983 | 1 |
| 1984 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2020 | 3 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
Applicants with the most clearances
Product code JDS| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 12 |
| Synthes (USA) Products LLC | 12 |
| Zimmer GmbH | 4 |
| Howmedica Corp. | 4 |
| Disco-O-Tech Medical Technologies, Ltd. | 2 |
| AAP Implantate AG | 1 |
| Acu Med, Inc. | 1 |
| Applied Osteo Systems, Inc. | 1 |
| Auxein medical Private Limited | 1 |
| Baumer S.A. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.